Independently from what stage your company is at, Rodon Biologics could help you in developing a biologics-manufacturing strategy early in the drug-development process. Rodon Biologics has in-house capability for development of biopharmaceutical products up pre-clinical stage. That includes scale-up and transfer of well characterised processes to cGMP facilities with whom Rodon Biologics has established collaborations over several years.

Analytical and bioassays development: tools to assure the quality (identity, purity, potency and stability) of the product and consistency/robustness of the production process.

Process transfer to GMP manufacturing: our knowledge of regulatory, GMP/GLP issues and documentation procedures ensures that we can develop a process and carry-out its transfer for manufacturing in compliance with the industry quality standards. On-going collaborations with GMP manufacturing facilities give the company the scope to supply materials produced according to cGMP.